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Completed

NCT Number: NCT02218307

The Use of Antibiotic Sinonasal Rinse After Sinus Surgery

Double blind placebo controlled trial to evaluate whether the routine use of nasal irrigation with mupirocin is more effective than saline irrigations alone in reducing symptoms of chronic rhinosinusitis in the early postoperative period.

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Key information

Conditions

Chronic Rhinosinusitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Miami Miller School of Medicine, ENT Dept

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronic Rhinosinusitis
  • Undergoing endoscopic sinus surgery

Exclusion criteria

  • Age under 18
  • Documented adverse reaction to mupirocin

Treatment and study plan

Mupirocin

Drug

Placebo

Drug

Primary outcomes

  1. Quality of Life in Chronic Rhinosinusitis Patients

    Time frame: 3 months

    Measuring the quality of life in chronic rhinosinusitis through completion of a questionnaire named SNOT 20 ( 20 questions for Sino-Nasal Outcome Test)

    Snot20:

    Scale 1 to 5 for 20 symptoms numbered below where 5 is the worst symptom. Total SNOT is scale from 0-100 where 100 is the worst.

    The following are the elements:

    • need to blow 2. sneezing 3. runny nose 4. cough 5. postnasal drip 6. Thick nasal discharge 7. Ear fullness 8. Dizziness 9. Ear pain 10. facial pain/pressure 11. difficulty falling asleep 12. wake up at night 13. lack of a good night's sleep 14. wake up tired 15. Fatigue 16. Reduced productivity 17. Reduced concentration 18. frustrated/ restless/irritable 19. sad 20. Embarrassed

Secondary outcomes

  1. Quality of Life in Chronic Rhinosinusitis Patients

    Time frame: 3 months

    Measuring the quality of life in chronic rhinosinusitis through completion of a questionnaire named Visual Analog Scale for Nasal Obstruction/Congestion. VAS for nasal obstruction is scale from 0 to 100 where 100 mean worse.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

The Use of Antibiotic Sinonasal Rinse After Sinus Surgery: A Randomized Double-Blind Control Trial

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Aug 18, 2014
Registry last updated
Jun 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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